AliveCor’s Heart Monitor for iPhone Receives FDA Clearance

SAN FRANCISCO--(BUSINESS WIRE)--AliveCor, Inc. announced today at the start of the 4th annual mHealth
Summit in Washington, D.C. that the company received FDA 510(k)
clearance on its mobile Heart Monitor as well as CE Mark conformity.
This clinical-quality, low-cost mobile ECG heart monitor, compatible
with the iPhone® 4 and 4S, enables doctors to evaluate patient heart
health easily, quickly and remotely.

“Our goal is to make health care cheaper, easier and more readily
available without losing quality of care”

Clinical studies of the device indicate that a high-quality
single-channel ECG can be rapidly and simply recorded using an iPhone
with the AliveCor application and device, to accurately screen for
cardiac arrhythmias including atrial fibrillation. Atrial fibrillation
is the most commonly occurring arrhythmia and carries a five-fold
increased risk of stroke.

Additionally, AliveCor’s founder, Dr. David Albert, and co-founders
Bruce Satchwell and Kim Barnett were granted U.S. Patent No. 8,301,232
for the device and technology. The three colleagues began working on the
heart-monitoring device in 2008.

“We believe that mobile ECGs and other breakthroughs in mobile health
can significantly change the way medicine is delivered,” Dr. Albert said.

The rhythm strips can be of any duration, and are stored on the iPhone
and securely in the cloud for later analysis, sharing and printing
through AliveCor’s secure website. The ECG data is sent wirelessly from
the Heart Monitor via AliveCor’s low-power, proprietary communication
protocol, and requires no pairing between the iPhone and the device.

The device incorporates electrodes into a case that snaps onto the back
of an iPhone 4 or 4S. The Heart Monitor is used by launching the
corresponding AliveECG app on the iPhone, holding the device in a
relaxed state, and pressing fingers from each hand to each of the two
appropriate electrodes on the device. The device can also be used to
obtain an ECG by placing it on the chest.

“Our goal is to make health care cheaper, easier and more readily
available without losing quality of care,” said AliveCor President and
CEO Judy Wade. “Our aspirations are significant; we’re out to make a
real difference.”

AliveCor’s Heart Monitor is available for pre-sale to medical
professionals in the U.S., beginning today, through the company website, www.alivecor.com.
The cost is $199. AliveCor plans to begin selling the Heart Monitor in
Europe in early 2013.

AliveCor, Inc., a privately held company headquartered in San Francisco,
CA, wants everyone to have their health at their fingertips. That's
why they make the vital health signs of people (and animals) around the
globe easily visible and actionable, at exceptionally low cost. This
improves everything from public health to the lives and possibilities of
people all over the world.

iPhone® is a trademark of Apple Inc., registered in the
U.S. and other countries.